Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands

Last updated: August 19, 2024
Sponsor: Amsterdam UMC, location VUmc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Neurologic Disorders

Multiple Sclerosis

Treatment

N/A

Clinical Study ID

NCT06567197
NL83783.018.23
  • Ages 18-65
  • All Genders

Study Summary

The goal of this observational study is to study the long-term effects of autologous hematopoietic stem cell transplantation (aHSCT) in people with highly active relapsing-remitting multiple sclerosis. The study will evaluate the following items:

  1. Disease activity

  2. Safety and tolerability of aHSCT

  3. Changes in the immune system

Participants will be subjected to frequent visits for five years after treatment with aHSCT. During these visits, clinical testing, evaluation by questionnaires, MRI scans and blood sampling will be performed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients approved for treatment with aHSCT in the Netherlands in accordance withthe Dutch criteria for aHSCT treatment for RRMS

Exclusion

Exclusion Criteria:

  • Contra-indications for treatment with aHSCT such as known hypersensitivity to themedication used for aHSCT

  • Clinically relevant comorbidities preventing safe use of medication used for aHSCT

  • Severe clinical depression

  • Active addiction to drugs or alcohol

  • Active infections such as but not limited to tuberculosis, cytomegalovirus,Epstein-Barr virus, herpes simplex, varicella zoster, viral hepatitis,toxoplasmosis, HIV or syphilis.

  • Active malignancy or history of malignancy with the exception of local basal cellcarcinoma or carcinoma in situ of the cervix

Study Design

Total Participants: 24
Study Start date:
August 25, 2023
Estimated Completion Date:
September 01, 2028

Connect with a study center

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Active - Recruiting

  • St. Antonius Hospital

    Nieuwegein,
    Netherlands

    Active - Recruiting

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